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    Clinical Trial Results:
    Supplémentation en vitamine D chez des enfants et adolescents suivis en néphrologie pédiatrique: étude de l’efficacité du protocole habituel de service (cholécalciférol) et de son impact sur la calciurie.

    Summary
    EudraCT number
    		 2013-002710-13
    Trial protocol
    		 FR  
    Global end of trial date
    17 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2021
    First version publication date
    03 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-812
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02238418
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospices Civils de Lyon
    Sponsor organisation address
    3 Quais des Célestins, Lyon, France, 69002
    Public contact
    Valérie Plattner, Hospices Civils de Lyon, +33 472115213, valerie.plattner@chu-lyon.fr
    Scientific contact
    Valérie Plattner, Hospices Civils de Lyon, +33 472406840, valerie.plattner@chu-lyon.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluer l’efficacité du protocole habituel de service de supplémentation en vitamine D prescrite selon les recommandations (adaptée au poids des enfants et à la concentration de base en 25 OH vitamine D) chez des enfants suivis en néphrologie pédiatrique pour MRC, transplantation rénale ou syndrome néphrotique chronique.
    Protection of trial subjects
    safety follow-up, signed consent by both parents
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Sep 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    18
    Adolescents (12-17 years)
    19
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients were recruited during their routine consultation

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 supplementation protocol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Patients above 60 kgs, 25-D levels:  < 25 nmol/L Cholecalciferol 100,000 IU: 1 ampoule every 2 weeks during 2 months (400,000 IU = 4 ampoules in total) 25–50 nmol/L Cholecalciferol 100,000 IU: 1 ampoule every 2 weeks during 6 weeks (300,000 IU = 3 ampoules in total) 50–75 nmol/L Cholecalciferol 100,000 IU: 1 ampoule every 2 weeks during 4 weeks (200,000 IU = 2 ampoules in total) Patients between 20 and 60 kgs,25-D levels:  < 25 nmol/L Cholecalciferol 100,000 IU: 1 ampoule every month during 2 months (200,000 IU = 2 ampoules in total) From 25 to 50 nmol/L Cholecalciferol 100,000 IU: 1 ampoule every 6 weeks during 2 months (200,000 IU = 2 ampoules in total) From 50 to 75 nmol/L Cholecalciferol 100,000 IU: 1 single ampoule Patients below 20 kgs with 25-D levels below 75 nmol/L Cholecalciferol 100,000 IU: 1 single ampoule

    Number of subjects in period 1
    		supplementation protocol
    Started
    37
    Completed
    35
    Not completed
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 37 37
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 10.9 (3.2 to 18.2) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 21 21
    Weight
    Units: kg
        median (full range (min-max))
    		 35.6 (11.9 to 81) -
    BMI
    Units: kg/m²
        median (full range (min-max))
    		 17.2 (13.3 to 30.1) -
    Age at transplantation
    Units: years
        median (full range (min-max))
    		 8.6 (1.3 to 17.3) -
    eGFR
    Units: ml/min/1.73m²
        median (full range (min-max))
    		 85 (13 to 198) -
    Height
    Units: cm
        median (full range (min-max))
    		 137 (92 to 181) -

    End points

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    End points reporting groups
    Reporting group title
    supplementation protocol
    Reporting group description
    		 -

    Primary: 25 OH vitamin D

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    End point title
    		 25 OH vitamin D [1]
    End point description
    evolution at baseline and 2 months after vitamin supplementation
    End point type
    Primary
    End point timeframe
    At baseline and at 2 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The system does not allow for statistical analysis for studies with a single treatment arm.p<0.05
    End point values
    		 supplementation protocol
    Number of subjects analysed
    35
    Units: nmol/L
    median (full range (min-max))
        At baseline
    50 (12 to 75)
        At 2 months
    76 (54 to 157)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Vitamin D supplementation
    Reporting group description
    		 -

    Serious adverse events
    		 Vitamin D supplementation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vitamin D supplementation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AE reported in this study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2014
    Add of biocollections Ethnic origin collection
    20 Oct 2015
    Recruitment period extension

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31873802
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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